Australian Drug Evaluation Committee - competing interest guidelines
Introduction
Members of ADEC and its subcommittees have been appointed on the basis of their expertise in the assessment of pharmaceutical products and their integrity to provide advice in the public interest. The pharmaceutical industry relies heavily on bodies outside industry, such as universities and hospitals, for product development. In this context, given their experience and expertise, it is likely that members of ADEC and its subcommittees have, or have had, some association with the pharmaceutical industry.
The issue of conflict of interest as it pertains to ADEC and its subcommittees is governed by Regulation 39 of the Therapeutic Goods Regulations - see Appendix 1.
It is the individual responsibility of all members to identify and disclose any real or potential for conflict of interest relating to an agenda item. It is the responsibility of the ADEC as a committee to deliberate on any real or potential for conflict of interest declared by a member, to determine whether a conflict of interest exists, and the member's subsequent preclusion, partial involvement or full involvement in the ADEC discussion of the relevant item.
Annual declaration
All members must advise the Chairman, through the Secretariat, on an annual basis, of:
- the names of relevant companies in which they have had a pecuniary interest, eg shares, consultancy, sponsorship, fellowship, research grant, travel grant, conference expenses, commissioned fee-paid work;
- the names of specific products and their companies for which they have had some involvement, eg clinical trial involvement, investigator, expert adviser.
Declaration of conflict of interest at meetings
If a member believes they have an identified competing interest with regard to an agenda item, it is their responsibility to declare that potential conflict and conduct themselves in accordance with the following guidelines with regard to any further consideration of that agenda item.
If a member believes that a potential for a conflict of interest exists with regard to an agenda item, they should declare that potential conflict of interest for deliberation and determination by the Committee. Following a declaration of a potential for conflict of interest, a member should absent himself or herself from the meeting while the Committee deliberates and makes its determination.
If the ADEC determines that a member does have a conflict of interest with an agenda item, the member's name and the determination of the Committee shall be recorded in the minutes.
Committee determinations of conflict of interest
- A member who has at any time been involved with a pharmaceutical product under consideration by the Committee and has personally received payment for that involvement, in any manner, including via an intermediary agent, from the pharmaceutical industry, should take no part in proceedings as they relate to the product.
- A member who has a current pecuniary interest in the pharmaceutical company concerned should take no part in proceedings as they relate to that product, except at the Chairman's discretion to answer questions from other members.
- A member who has a current pecuniary interest relating to a product which is competitor to the product under consideration should declare their interest in the competitor company and take no part in proceedings, except at the Chairman's discretion to answer questions from other members.
- A member who has had a particular involvement in the development of a pharmaceutical product (eg sitting on an Advisory Board or a principal investigator involved in the design of clinical trial protocols) which they believe constitutes a potential for conflict of interest, should declare this for determination by the Committee.
- Involvement in pharmaceutical industry-sponsored trials by the provision of patients for inclusion in a multi-centre trial, participation in investigators' meetings, where the member does not have an involvement in the trial design, monitoring or preparation of trial report should be declared by the member. This should not preclude the member from active and full participation in the meeting, unless the member believes that their particular involvement has provided them with a conflict of interest.
Points of clarification
By virtue of their experience and expertise, it is anticipated that ADEC members will have, or have had some involvement with pharmaceutical industry-sponsored pharmaceutical research.
As can be deduced from these guidelines, the ability of an ADEC member to function as an effective member of the Committee will be significantly reduced if that member accepts a pecuniary interest from the pharmaceutical industry. This situation is minimised if ADEC members aim to avoid, where possible, those activities that constitute competing interests.
Involvement as an investigator in pharmaceutical industry-sponsored trials funded to cover actual costs involved (including costs to attend investigators' meetings) would conform to point 5 (not point 1) of the above guidelines.
M Tattersall
April 1999
Appendix 1
Therapeutic Goods Regulations
Regulation 39 Disclosure of interest
- A Member of a Committee established under this Part who has a direct or indirect pecuniary interest in a matter being considered or about to be considered at a meeting of the committee must, as soon as possible after the relevant facts have come to the Member's knowledge, disclose the nature of the interest at a meeting of the Committee.
- The disclosure is to be recorded in the minutes of the meeting and the Member must not, unless the Committee otherwise determines:
- be present during any deliberation of the Committee with respect to the matter; or
- take part in any decision of the Committee with respect to that matter.
- For the purpose of the making of a determination in relation to the Member who has made the disclosure, any Member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates to must not:
- be present during any deliberation of the Committee for the purpose of making the determination; or
- take part in the making of the determination by the Committee.